Sarilumab

By

Generic Name: Sarilumab Brand Name(s): Generics only. No brands available. Avability: Rx Pregnancy Category: N

Uses

What is Sarilumab used for?

Sarilumab is used alone or with other medications to treat moderate to severe rheumatoid arthritis. It helps to reduce pain and swelling due to rheumatoid arthritis. Sarilumab belongs to a class of drugs known as monoclonal antibodies. It works by blocking Interleukin-6, a substance made by the body that causes swelling (inflammation) in areas affected by rheumatoid arthritis.

How should I take Sarilumab?

Remove this medication from the refrigerator and leave it at room temperature for at least 30 minutes before injecting. Do not warm up this medication any other way such as by heating in the microwave or placing in hot water. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid.

Inject this medication under the skin of the thigh, abdomen, or upper arm as directed by your doctor, usually once every 2 weeks. Before injecting each dose, clean the injection site with rubbing alcohol. Change the injection site each time to lessen injury under the skin. Do not inject into skin that is tender, damaged, or has bruises or scars.

Learn how to store and discard medical supplies safely.

The dosage is based on your medical condition, lab tests, and response to treatment.

Use this medication regularly to get the most benefit from it. To help you remember, mark the days you need to inject the medication on a calendar.

Tell your doctor if your condition does not get better or if it gets worse.

How do I store Sarilumab?

Store the prefilled syringes in their original container in a refrigerator. Protect from moisture and light. Do not freeze.

A prefilled syringe must be used within 14 days if you keep it at room temperature.

There may be different brands of Sarilumab that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Sarilumab down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Sarilumab?

Before using sarilumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, past/current/returning infections, liver problems, blood/bleeding problems, stomach/abdominal problems (such as ulcers, diverticulitis).

Sarilumab can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, tuberculosis, flu). Tell your doctor if you live in, have lived in, or have traveled to certain areas where there is an increased chance of getting certain kinds of fungal infections (blastomycosis, coccidioidomycosis, histoplasmosis). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

Drugs that affect the immune system (such as sarilumab) may increase your risk of certain cancers. Tell your doctor if you have ever had any type of cancer.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Sarilumab during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Sarilumab. Sarilumab is pregnancy risk category N according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Sarilumab?

Irritation, redness, or pain at the injection site may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: severe stomach/abdominal pain.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Sarilumab?

Irritation, redness, or pain at the injection site may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: severe stomach/abdominal pain.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Sarilumab may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Sarilumab?

Sarilumab may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Sarilumab?

Sarilumab may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Sarilumab.

What is the dose of Sarilumab for an adult?

Usual Adult Dose for Rheumatoid Arthritis

200 mg subcutaneously every 2 weeks

Comments:

-This drug may be used as monotherapy or in combination with methotrexate (MTX) or other conventional DMARDs.

-Test patients for latent tuberculosis (TB); if positive, consider treating for TB prior to initiating therapy.

-Avoid using this drug with biological DMARDs because of the possibility of increased immunosuppression and increased risk of infection; concurrent use with biological DMARDs such as TNF antagonists, IL-1R antagonists, anti-CD20 monoclonal antibodies and selective co-stimulation modulators has not been studied.

-Avoid use in patients with active infections.

Use: For the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs)

Renal Dose Adjustments

Mild to moderate renal impairment: No adjustment recommended.

Liver Dose Adjustments

The safety and efficacy of this drug have not been studied in patients with hepatic impairment, including patients with positive HBV or HCV serology.

Dose Adjustments

-If a patient develops a serious infection, hold therapy until the infection is controlled.

-This drug is not recommended in patients with an absolute neutrophil count (ANC) less than 2000/mm3, platelet count less than 150,000/mm3, or who have ALT or AST above 1.5 times the upper limit of normal (ULN).

Nonhematologic toxicity:

-Hypersensitivity (anaphylaxis or other clinically significant hypersensitivity reaction): Permanently discontinue therapy.

-Infection (serious): Interrupt therapy until the infection is controlled.

DOSE MODIFICATIONS:

-Absolute Neutrophil Count (ANC):

1) ANC greater than 1000/mm3: No dose adjustment recommended.

2) ANC 500 to 1000/mm3: Hold therapy until ANC is greater than 1000/mm3 then resume therapy at 150 mg subcutaneously every 2 weeks and increase to 200 mg subcutaneously every 2 weeks as clinically appropriate.

ANC less than 500/mm3: Discontinue therapy.

-Low Platelet Count:

1) Platelets 50,000 to 100,000/mm3: Hold therapy until platelets are greater than 100,000/mm3 then resume therapy at 150 mg subcutaneously every 2 weeks and increase to 200 mg subcutaneously every 2 weeks as clinically appropriate.

2) Platelets less than 50,000/mm3: Discontinue therapy if confirmed by repeat testing.

-Liver Enzyme Abnormalities:

1) ALT greater than 1 to less than or equal to 3 x ULN: Adjust concomitant DMARDs as appropriate.

2) ALT greater than 3 to less than or equal to 5 x ULN: Interrupt therapy; when ALT is less than 3 x ULN, resume therapy at 150 mg subcutaneously every 2 weeks and increase to 200 mg subcutaneously every 2 weeks as clinically appropriate.

3) ALT greater than 5 x ULN: Discontinue therapy.

Other Comments

Administration advice:

-This drug is intended for use under the guidance of a healthcare professional.

-A patient may self-inject or the patient’s caregiver may administer this drug after proper training.

-Rotate injection sites with each injection. Do not inject into skin that is tender, damaged, or has bruises or scars.

Reconstitution/preparation techniques:

-Allow the prefilled syringe to sit at room temperature for 30 minutes prior to injection. Do not warm in any other way.

-Inspect the syringe contents visually for particulate matter and discoloration prior to administration. The solution should be clear and colorless to pale yellow. Do not use if the solution is cloudy, discolored or contains particles, or if any part of the prefilled syringe appears to be damaged.

What is the dose of Sarilumab for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Sarilumab available?

Sarilumab is available in the following dosage forms and strengths:

  • Subcutaneous solution.

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Sarilumab, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Review Date: August 10, 2018 | Last Modified: August 10, 2018

Sources
You might also like